Latest Regulatory Approvals News

Hydrix Limited’s subsidiary has landed a significant A$2.5 million contract to develop SynCardia’s next-generation fully implantable Total Artificial Heart, marking a major step in advanced cardiovascular technology.

Neuren Pharmaceuticals has published promising Phase 2 trial results for NNZ-2591 in Phelan-McDermid syndrome, underpinning its ongoing Phase 3 Koala trial recruiting in the US.

CurveBeam AI has received official Chinese regulatory approval for a strategic $10 million investment from WEGO Orthopaedics, marking a major step in its expansion into Greater China. The initial $4 million tranche at a premium share price is expected imminently, underpinning a decade-long commercialisation deal.

Capricorn Metals reports solid Q2 gold production at Karlawinda, maintaining momentum towards the upper end of its FY26 guidance while advancing major expansion projects.

Manuka Resources is gearing up to recommence gold and silver production in the Cobar Basin by mid-2026 while awaiting a pivotal regulatory decision on its large-scale iron sands project in New Zealand.

Janus Electric has secured full California Air Resources Board approval for its JCM 540 battery-electric truck conversion system, enabling fleet operators to access up to US$90,000 in government vouchers per vehicle. This milestone accelerates Janus’ entry into the lucrative California zero-emission freight market.

American Tungsten & Antimony Ltd is set to submit a Notice of Intent for its first diamond drilling program at the Tennessee Mountain Tungsten Project in Nevada, aiming to validate historic high-grade mineralisation and establish a formal resource estimate.

Nexsen Limited has initiated FDA engagement for its rapid Group B Streptococcus diagnostic sensor, aiming for expedited US market entry, while bolstering its leadership team and scientific credentials.

AusQuest Limited has significantly extended the copper-gold mineralised system at its Cangallo project in Peru through recent diamond and RC drilling, revealing depths beyond 800 metres and strike length exceeding one kilometre.

Medallion Metals Limited has opened a Share Purchase Plan offering eligible shareholders in Australia and New Zealand the chance to buy shares at a 20.8% discount, aiming to raise $5 million for advancing its Forrestania and Cosmic Boy projects.

Temas Resources has fortified its position in the critical minerals sector through key strategic moves including joining Québec’s CSM Scientific Network, engaging market-making services, and commissioning independent equity research.

BlinkLab Limited has secured independent scientific validation for its smartphone-based autism diagnostic technology through publication in the prestigious journal Autism Research, marking a significant milestone ahead of its FDA regulatory trial.